Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- HJFMagnifier, Hand-Held, Low-Vision1Product Code
- HJGSystem, Reading, Television, Closed-Circuit1Product Code
- HJHLoupe, Binocular, Low Power1Product Code
- HJXReader, Prism, Ophthalmic1Product Code
- HJYReader, Bar, Ophthalmic1Product Code
- HJZCrutch, Ptosis1Product Code
- HKBTelescope, Hand-Held, Low-Vision1Product Code
- HKCSpectacle Microscope, Low-Vision1Product Code
- HKKTelescope, Spectacle, Low-Vision1Product Code
- HOISpectacle, Magnifying1Product Code
- HOTAid, Vision Image Intensification1Product Code
- HPEAid, Vision, Optical, Battery-Powered1Product Code
- HPFAid, Vision, Electronic, Ac-Powered1Product Code
- HPGAid, Vision, Electronic, Battery-Powered1Product Code
- HPIAid, Vision, Optical, Ac-Powered1Product Code
- HQDLens, Contact (Other Material) - Daily2Product Code
- HQGLens, Spectacle, Non-Custom (Prescription)1Product Code
- HQYSunglasses (Non-Prescription Including Photosensitive)1Product Code
- HQZFrame, Spectacle1Product Code
- HRCSterilizer, Soft-Lens, Thermal, Battery-Powered2Product Code
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered2Product Code
- HRLUnit, Beta, Radiation, Ophthalmic2Product Code
- KYEInserter/Remover Contact Lens1Product Code
- LPLLenses, Soft Contact, Daily Wear2Product Code
- LPMLenses, Soft Contact, Extended Wear3Product Code
- LPNAccessories, Soft Lens Products2Product Code
- LRXCase, Contact Lens2Product Code
- K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)2Cleared 510(K)
- K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)2Cleared 510(K)
- K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc2Cleared 510(K)
- K172925Contact Lens Case, Model: A-1, B-12Cleared 510(K)
- K173365Bausch + Lomb Boston Scleral Lens Case2Cleared 510(K)
- K171539Contact Lens Case2Cleared 510(K)
- K171163Contact Lens Case Round Glasses2Cleared 510(K)
- K162869Contact Lens Case2Cleared 510(K)
- K160005Contact Lens Case (multiple brand name)2Cleared 510(K)
- K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case2Cleared 510(K)
- K143351iCase Contact Lens Case2Cleared 510(K)
- K140488CONTACT LENS CASE2Cleared 510(K)
- K131783POLAROID CONTACTSPOD2Cleared 510(K)
- K130930OWL CONTACT LENS CASES, DOG CONTACT LENS CASES2Cleared 510(K)
- K131875MENICON NECT CONTACT LENS CASE2Cleared 510(K)
- K130753STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE2Cleared 510(K)
- K122700PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES2Cleared 510(K)
- K130285PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS2Cleared 510(K)
- K120904POLARIS DIAL-A-DATE CONTACT LENS CASE2Cleared 510(K)
- K120969AC LENS BRANDED CONTACT LENS CASE2Cleared 510(K)
- K121030SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE2Cleared 510(K)
- K112832EYE CARE CURE CONTACT LENS CASE2Cleared 510(K)
- K111856SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE2Cleared 510(K)
- K093377POLARIS CONTACT LENS CASE2Cleared 510(K)
- K090362IMAG, IPOD, EZ-FIND AND ISLIDE2Cleared 510(K)
- K071081CONTACT LENS CASE2Cleared 510(K)
- K052809SAUFLON FLAT COLOURED LENS CASE2Cleared 510(K)
- K041820SOLO-CARE AQUA ANTIMICROBIAL LENS CASE2Cleared 510(K)
- K042578I-PROMOTIONS CONTACT LENS CASE2Cleared 510(K)
- K040914POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS2Cleared 510(K)
- K033656SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE2Cleared 510(K)
- K032309NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY2Cleared 510(K)
- K030987CONTACT LENS STORAGE CASE2Cleared 510(K)
- K021248ICASE2Cleared 510(K)
- K013232CYBERCASES BY BAUSCH & LOMB2Cleared 510(K)
- K991206BONASSE CONTACT LENS CASE2Cleared 510(K)
- K993487PARAGON LENS VIAL2Cleared 510(K)
- K993486PARAGON LENS CARRIER2Cleared 510(K)
- K974635PARAGON LENS CARE2Cleared 510(K)
- K974281ALCON CONTACT LENS CASE2Cleared 510(K)
- K971618ALCON CONTACT LENS CASE2Cleared 510(K)
- K962512BOSTON CONTACT LENS CASE2Cleared 510(K)
- K950869JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE2Cleared 510(K)
- K951552BOSTON CONTACT LENS CASE2Cleared 510(K)
- K951182RYDER CONTACT LENS CASE MODEL 106702Cleared 510(K)
- K951181RYDER CONTACT LENS CASE2Cleared 510(K)
- K950878MENICON SP VIAL2Cleared 510(K)
- K950530PRO-TEC-CASE2Cleared 510(K)
- K945259DATEMINDER CONTACT LENS CASE2Cleared 510(K)
- K943921RYDER CONTACT LENS CASE2Cleared 510(K)
- K943183CIBA VISION(R) CONTACT LENS CASE2Cleared 510(K)
- K931620OPTI-FREE CONTACT LENS CASE2Cleared 510(K)
- K923458CONTACT LENS CASE2Cleared 510(K)
- K920064OPTI-LENS CONTACT LENS CASE2Cleared 510(K)
- K915082OPTI-LENS(TM) CONTACT LENS CASE2Cleared 510(K)
- K901748KESTREL LENS CASE (208-12NT POLYSTYRENE)2Cleared 510(K)
- K900778ITEM #272 MAGNIF-EYES CONTACT LENS CASE2Cleared 510(K)
- K900777ITEM #273 CONTACT LENS CASES2Cleared 510(K)
- K897085COMFEES(R) + CON-PAK(TM) LENS CASE2Cleared 510(K)
- K897084CONFEES(R)+ CONTACT LENS HOLDER2Cleared 510(K)
- K900053KESTREL LENS CASE 731H-893S/P-1700-26112Cleared 510(K)
- K900054KESTREL LENS CASE 1543-893S/P-1700-26112Cleared 510(K)
- K895167THE OPTIC BOX CONTACT LENS CASE2Cleared 510(K)
- K896685BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM2Cleared 510(K)
- K890533ITEM #352/#CS352* CONTACT LENS CASES2Cleared 510(K)
- K882384DELUXE CONTACT LENS HOLDER (HARD & SOFT) #2832Cleared 510(K)
- K884251ALLERGAN LENS CASE2Cleared 510(K)
- K873820MOBAY (BAYER) MAKROLON 2658 11122Cleared 510(K)
- K873823MOBAY (BAYER) MAKROLON 2658 32912Cleared 510(K)
- K873822MOBAY (BAYER) MERLON M-40 (H)F 11122Cleared 510(K)
- K873821GE NORYL 731-80089S2Cleared 510(K)
- K873825GE LEXAN 144R 1122Cleared 510(K)
- K873824RED #467, #457, BLUE #437, GREEN #447 MINDEL S10002Cleared 510(K)
- K875197OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE2Cleared 510(K)
- K874657RIGID-LENS CASE2Cleared 510(K)
- K871741EASY EYES TM LENS CARRYING CASE2Cleared 510(K)
- K870164SUMMIT OPTICS SOFT CONTACT LENS CASE2Cleared 510(K)
- K853727KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)2Cleared 510(K)
- K840692CONTACT LENS CASE FOR SOFT LENSES2Cleared 510(K)
- K840691CONTACT LENS CASE FOR RIGID GAS PERMA2Cleared 510(K)
- LYLAccessories, Solution, Ultrasonic Cleaners For Lenses2Product Code
- MMLWeights, Eyelid, External2Product Code
- MRCProducts, Contact Lens Care, Rigid Gas Permeable2Product Code
- MUWLens, Contact (Orthokeratology)2Product Code
- MVNLens, Contact, (Disposable)2Product Code
- MWLLens, Contact (Rigid Gas Permeable), Extended Wear3Product Code
- MZDSystem, In-Office Tinting, Contact Lenses2Product Code
- NAILens, Prescription, Color Deficiency1Product Code
- NCBWeights, Eyelid, Implantable2Product Code
- NCZLens, Contact, For Color Vision Deficiency2Product Code
- NICLens, Contact, For Reading Discomfort2Product Code
- NJHLens, Spectacle (Prescription), For Reading Discomfort1Product Code
- NUULens, Contact, Orthokeratology, Overnight3Product Code
- ORZEyelid Thermal Pulsation System2Product Code
- PICOral Electronic Vision Aid2Product Code
- PLXTear Duct Occluder1Product Code
- PQJIntranasal Electrostimulation Device2Product Code
- QBRIntranasal Electrostimulation Device For Dry Eye Symptoms2Product Code
- QIUIntense Pulsed Light Device For Managing Dry Eye2Product Code
- QKVElectromechanical Tear Stimulator2Product Code
- QMMHydrophilic Re-Coating Solution2Product Code
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ICASE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K021248
- 510(k) Type
- Traditional
- Applicant
- IKEEPS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/24/2002
- Days to Decision
- 158 days
- Submission Type
- Statement